The Best Prescription for Pre-Emption

On Tuesday, the Supreme Court will hear arguments in Mutual Pharmaceutical v. Bartlett, a case about the ability of consumers to bring lawsuits against the makers of generic drugs. A central issue is the Food and Drug Administration’s doctrine of federal “pre-emption,” meaning that state tort law cannot trump FDA regulation. In Bartlett____, the manufacturer is being sued for selling an allegedly flawed drug that was nevertheless approved by the FDA, which also regulated the manufacturer’s exact formula.

The pre-emption doctrine, urged by the FDA during the Bush administration, was established to protect the agency’s ability and authority to regulate the safety and effectiveness of drugs nationwide. The left detested pre-emption, since it impeded the ability of trial lawyers to bring big dollar lawsuits in state courts challenging FDA regulatory decisions.

The American Association for Justice—the trial lawyers lobby—claims that “pre-emption of state law means complete immunity from lawsuits for corporations and a full escape from accountability when they have knowingly injured and endangered Americans.” It means nothing of the sort. Pre-emption means that if a federal agency is to regulate drugs, it must be able to set nationwide standards. Otherwise, we will be subject to a crazy-quilt world of different legal regimes in each state that would make the production of lifesaving medications difficult or impossible.

A recent ruling by the First U.S. Circuit Court of Appeals brought us closer to that problematic place. In May 2012, the Boston-based federal court affirmed a $21 million award to plaintiff Karen Bartlett based on her claim that the generic prescription anti-inflammatory pain reliever sulindac has a design flaw. Weeks after she began taking the drug for shoulder pain, Ms. Bartlett experienced apparent hypersensitivity and severe symptoms such as skin peeling and blindness. She sued for damages.

What happened to Ms. Bartlett was tragic, but her lawyers’ argument that a generic drug had a “design flaw” is itself flawed. Under federal law, a generic manufacturer must produce the product under the design approved by the FDA. The jury award made the generic manufacturer liable for something it had no capacity to change. In affirming the jury’s original verdict, the Appeals Court acknowledged that its decision was “second-guessing the FDA.”

The branded pharmaceutical industry—which is usually at odds with generic manufacturers over patents and other competition issues—recognized the danger that the design-flaw argument poses to all drug research and development. It has sided with Mutual Pharmaceutical. In another interesting twist, the Obama administration also has come out in favor of the defendants.

The government has had a mixed record on pre-emption. In Wyeth v. Levine (2009), the government had argued that a claim in state court that the warning label on a brand-name drug was inadequate was pre-empted. (The Supreme Court disagreed because federal law allows a brand-name company to change its warnings.)

Only a few months after President Obama took office, the administration issued an executive order skeptical of pre-emption. In Pliva v. Mensing (2011), the government argued that a warnings claim against a generic company was not pre-empted because, while generics cannot independently change their product warnings under federal law, they could ask the FDA to do so. (The Supreme Court disagreed, holding, among other things, that asking the FDA to change the label wouldn’t satisfy state law.)

In Bartlett, however, the Obama administration appears to support pre-emption, arguing that Congress has given the authority to the FDA to make expert judgments on drug safety, and that these determinations should be made “on the basis of sound scientific judgments” and not by nonexpert juries. The administration’s stance also shows how concerned it is about the danger the original Bartlett ruling poses for biomedical innovation and the FDA’s regulatory authority. Unlike past cases, this one, with its design-defect claim, directly challenges the FDA’s very authority to approve a product in the first place.

For all of its imperfections, the FDA is the nation’s pre-eminent drug regulatory body, and its ability to approve products goes to the heart of our health-care system. If the Supreme Court rules that nonexpert juries can second-guess the decisions of FDA scientists, then manufacturers would rightfully be reluctant to produce lifesaving, life-extending medications, which provide the U.S. and the world with enormous health-care and economic benefits. No wonder the Obama administration has recognized that this case is a bridge too far.